← FDA Drug Approvals (Drugs@FDA)

VALRUBICIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 2019-04-19

Drug application

FDA Application #

ANDA206430

Application type

Abbreviated New Drug Application (Generic)

Brand name

VALRUBICIN

Generic name

VALRUBICIN INTRAVESICAL SOLUTION

Active ingredients

VALRUBICIN

Dosage form

SOLUTION

Route

INTRAVESICAL

Marketing status

Prescription

Sponsor

HIKMA

Manufacturer

Hikma Pharmaceuticals USA Inc.

First approval

2019-04-19

Source

Authoritative

Drugs@FDA application overview

Machine

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